Quality Management System Officer - บริษัท ไอเมด ลาบอราทอรี่ จำกัด

Work Location: Innotech Laboratory Service Co., Ltd.

• Manage and control internal organizational documents and documents with external parties, including all documentation related to the Quality Management System (QMS).
• Maintain and update quality system documents to ensure they remain current and compliant with applicable standards and regulatory requirements.
• Provide guidance and support to departments and employees on the proper use of work instructions, standard operating procedures (SOPs), and document control practices.
• Review, monitor, and control document records; design and improve document control systems and processes to enhance efficiency, accessibility, and traceability.
• Investigate root causes, monitor corrective actions, and collaborate with relevant departments to resolve quality-related issues.
• Ensure compliance with quality management standards and oversee the implementation of quality system requirements.
• Monitor and follow up on customer complaints within the Quality Management System, ensuring timely resolution in accordance with service quality, laboratory safety, and medical device regulatory requirements.
• Analyze quality and safety data to identify trends, risks, and recurring issues, and recommend preventive and continuous improvement initiatives.
• Prepare and submit monthly Quality Management System (QMS) performance reports.
• Maintain, organize, and archive all documents and records related to quality certifications, standards, and regulatory compliance.
• Prepare, distribute, control, and retrieve controlled manuals and documents, including the recall of obsolete versions from all departments.
• Coordinate and communicate effectively with internal departments and external organizations.
• Develop, maintain, and update policies, procedures, and work instructions in accordance with organizational policies and applicable standards.
• Monitor changes in regulatory and industry requirements and update organizational processes to ensure ongoing compliance.
• Coordinate and support internal audits and external audits conducted by certification bodies and regulatory authorities.
• Perform other duties and special assignments as assigned.

• Bachelor's degree in Quality Management, Science, Engineering, Business Administration, or a related field.
• Minimum of 5 years of experience in Quality Management Systems (QMS), Document Control, or Quality Assurance, with expertise in quality control systems and operational standards.
• Proven experience in auditing, monitoring, and maintaining documentation and operational processes in compliance with recognized standards, such as ISO 9001, ISO 13485, ISO 27001, ISO 27799, GMP, and other applicable quality management standards.
• Strong knowledge and hands-on experience with Document Management Systems (DMS) or other related document control software.
• Proficient in Microsoft Office Suite, particularly Word, Excel, PowerPoint, and Outlook.
• Excellent document review, editing, formatting, and document control skills to ensure compliance with organizational and regulatory requirements.
• Strong communication skills with excellent proficiency in Thai and good command of English, both written and spoken.
• Highly responsible, detail-oriented, able to work effectively under pressure, with strong problem-solving abilities and excellent interpersonal skills.